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Trial record 62 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Bioequivalence of Telmisartan / HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02262598
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To establish the bioequivalence of fixed dose combination of 40 mg telmisartan / 12.5 mg HCTZ vs. its monocomponents

Condition or disease Intervention/treatment Phase
Healthy Drug: Telmisartan Drug: Hydrochlorthiazide (HCTZ) Drug: Telmisartan/HCTZ fixed dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence of 40 mg Telmisartan / 12.5 mg HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
Study Start Date : September 2004
Actual Primary Completion Date : October 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Telmisartan/HCTZ fixed dose Drug: Telmisartan/HCTZ fixed dose
Active Comparator: Telmisartan and HCTZ monocomponents Drug: Telmisartan
Drug: Hydrochlorthiazide (HCTZ)



Primary Outcome Measures :
  1. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: Up to 72 hours after drug administration ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]

Secondary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 72 hours after drug administration ]
  2. tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  3. λz (terminal rate constant of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  4. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  5. MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: Up to 72 hours after drug administration ]
  6. Number of participants with abnormal findings in physical examination [ Time Frame: Up to 9 days after last drug administration ]
  7. Number of participants with clinically significant findings in vital signs [ Time Frame: Up to 9 days after last drug administration ]
  8. Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram) [ Time Frame: Up to 9 days after last drug administration ]
  9. Number of participants with clinically significant findings in laboratory parameters [ Time Frame: Up to 9 days after last drug administration ]
  10. Number of participants with adverse events [ Time Frame: Up to 9 days after last drug administration ]


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males according to the following criteria:

    Based upon a complete medical history, the physical examination (physical findings and measurements of height and body weight), vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests

    • No finding of clinical relevance
    • No evidence of a clinically relevant concomitant disease
  2. Age ≥20 years and Age ≤35 years
  3. BMI ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)(MHW Ordinance No. 28, as of Mar. 27, 1997) and the local legislation.

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  2. Surgery of gastrointestinal tract (except appendectomy)
  3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  4. History of relevant orthostatic hypotension, fainting spells or blackouts.
  5. Chronic or relevant acute infections
  6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  7. Positive result for Hepatitis B virus surface antigen (HBsAg), anti Hepatitis C virus (HCV) anti bodies, syphilitic test or Human immunodeficiency virus (HIV) test
  8. Intake of drugs with a long half-life (≥24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial.
  10. Participation in another trial with an investigational drug within four months prior to administration or during the trial
  11. Smoker (more than 20 cigarettes/day)
  12. Inability to refrain from smoking during hospitalisation
  13. Alcohol abuse (more than 60 g/day as ethanol ex.) three middle sized bottles of beer / three gous (equivalent to 540 mL) of sake)
  14. Drug abuse
  15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  16. Excessive physical activities (within one week prior to administration or during the trial)
  17. Any laboratory value outside the reference range that is of clinical relevance
  18. Inability to comply with dietary regimen of study centre
  19. Any other volunteers whom, the principal investigator or sub investigator would not allow to participate this study

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02262598     History of Changes
Other Study ID Numbers: 502.437
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators